KR20210013189A - External catheter, external catheter-related components, external-catheter kit with step-by-step instructions, and methods thereof (EXTERNAL CATHETERS, EXTERNAL CATHETER-RELATED COMPONENTS, EXTERNAL-CATHETER KITS WITH STEP-BY-STEP INSTRUCTIONS, AND METHODS THEREOF) - Google Patents

Abstract

External catheter, external catheter-related components, external-catheter kits having step-by-step instructions and a method for providing a standardized system for the application and management of these catheters. In one embodiment, an external-catheter kit may include one or more external catheters, a cleaning kit, and step-by-step instructions for using the external catheter kit. The cleaning kit may include one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more external catheters. Step-by-step instructions for using an external catheter kit may include step-by-step instructions for anatomical cleaning, external-catheter application, and external-catheter care after external-catheter application. The one or more external catheters may be selected from male external catheters and female external catheters.

Description

External catheter, external catheter-related components, external-catheter kit with step-by-step instructions, and methods thereof (EXTERNAL CATHETERS, EXTERNAL CATHETER-RELATED COMPONENTS, EXTERNAL-CATHETER KITS WITH STEP-BY-STEP INSTRUCTIONS, AND METHODS THEREOF)

The present disclosure relates to an external catheter, external catheter-related components, an external-catheter kit with step-by-step instruction, and a method thereof.

Hospitals across the country are naturally focusing their efforts on reducing the risk of catheters-associated urinary tract infections (“CAUTI”) in response to at least the great penalties imposed by the Affordable Care Act (“ACA”). have. The steps taken to reduce the risk, such as indwelling catheter-related infections, are the implementation of various preventive measures recommended by the Centers for Disease Control and Prevention (“CDC”) as well as non-induction catheter alternatives. Includes reducing the utilization of indwelling catheters through the use of With the use of non-attracting catheters, such as external-catheter, which is expected to increase, it is expected that the application of such catheters and problems related to management after application will also increase.

External catheters, external catheter-related components, external-catheter kits with step-by-step instructions, and methods thereof that provide a standardized system for the application and management of these catheters are disclosed herein.

External-catheter kits are disclosed herein. In accordance with some embodiments, an external-catheter kit includes one or more external catheters, a cleaning kit, and step-by-step instructions for using the external-catheter kit. The cleaning kit includes one or more individually wrapped towelettes for at least anatomical cleansing prior to application of an external catheter of any one of the one or more external catheters. Step-by-step instructions include step-by-step instructions for anatomical cleaning, external-catheter application, and external-catheter care after external-catheter application.

In some embodiments, the external-catheter kit further comprises a urine-draining system. The urine-draining system includes a urine-collection container, a urine-drainage tubing, and one or more connectors for fluidly connecting an external catheter of one of the one or more external catheters to a urine-collection device.

In some embodiments, the urine-draining system is pre-assembled at least partially in an external-catheter kit to minimize erroneous connections and contamination based on erroneous connections. The urine-draining tubing is fluidly connected to the urine-collection container in a partially pre-assembled urine-draining system.

In some embodiments, the one or more external catheters are female external catheters (“FEC”). One or more FECs are optionally individually packaged.

In some embodiments, the external-catheter kit further comprises an FEC urine-draining system. The FEC urine-draining system includes a urine-collection canister, a lid configured to cover the urine-collection canister, a urine-drain tubing, and one or more FECs in the urine-collection canister. And one or more connectors for fluidic connection.

In some embodiments, the FEC urine-draining system is pre-assembled at least partially in an external-catheter kit to minimize erroneous connections and contamination based on erroneous connections. The urine-drain tubing is partially fluidly connected to the urine-collecting vessel through a lid that covers the urine-collecting vessel in a pre-assembled FEC urine-draining system.

In some embodiments, the outer-catheter kit further includes a urine-privacy cover configured to form a sleeve to cover the urine-collecting container. The sleeve has a cut-out window configured to expose the graduations on the urine-collector through the window of the sleeve while the remaining portion of the urine-collector is covered by the sleeve.

In some embodiments, the one or more external catheters are male external catheters (“MECs”). One or more MECs are optionally individually packaged.

In some embodiments, each of the one or more MECs has a different size. One or more MECs each represent the most common MEC size or sizes.

In some embodiments, the one or more MECs are 5 different sized MECs.

In some embodiments, the external-catheter kit further comprises a MEC sizer having cutouts of at least 5 different sizes to determine an appropriate MEC size for the user or patient. .

In some embodiments, each cutout of the cutouts has a border with different colors around the cutout according to the color-based MEC size-indicating system. Each of the one or more MECs has a different color depending on the MEC size-indicating system.

In some embodiments, the external-catheter kit further comprises a MEC urine-draining system. The MEC urine-draining system includes a urine-collection bag, a urine-drainage tubing, and a connector assembly for fluidly connecting one of the one or more MECs to the urine-collection bag.

In some embodiments, the urine-draining bag is a bedside bag or leg bag.

In some embodiments, the connector assembly includes a fixed tubing connector having a urine-sampling port, and a flexible tubular bridge configured to connect to the MEC's flexible tubing connector. Each tubing connector of the flexible tubing connector and the fixed tubing connector is a bidirectional tubing connector.

In some embodiments, each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to insert into an opposite end portion of the flexible bridge. The fixed tubing connector has a non-tapered end portion configured to insert into the end portion of the urine-draining tubing. The flexible tubing connector has a non-tapered end portion configured to insert into an end portion of any one of one or more MECs configured for urine drainage.

In some embodiments, the external-catheter kit further includes a securing device configured to secure the rigid tubing connector of the connector assembly to the patient's leg. The fixation device minimizes any end or transverse movement of the drain tubing during use.

In some embodiments, the MEC urine-draining system is pre-assembled at least partially in an external-catheter kit to minimize erroneous connections and contamination based on erroneous connections. Urine-drain tubing fluidly connects the connector assembly to a urine-draining bag in a partially pre-assembled MEC urine-draining system.

In some embodiments, step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the outer-catheter kit, and optionally, as one or more components of the outer-catheter kit are removed from the outer-catheter kit. Is visible or a combination of these.

In some embodiments, the package may include a wrap of a first sterilizable material around the components of the outer-catheter kit or a tray of second sterilizable material on which the components of the outer-catheter kit are located. The packaging further includes outer packaging around the wrap or tray. The outer packaging is configured to sterilize the components of the outer-catheter kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the outer-catheter kit.

In some embodiments, also disclosed herein is an FEC kit comprising one or more FECs, a cleaning kit, and step-by-step instructions for using the FEC kit. One or more FECs are optionally individually packaged. The cleaning kit includes one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more FECs. Step-by-step instructions for using the FEC kit include instructions for anatomical cleaning, FEC application, and FEC management after FEC application.

In some embodiments, the FEC kit further comprises a urine-draining system. The urine-draining system includes a urine-collection canister, a lid configured to cover the urine-collection canister, a urine-draining tubing, and an FEC of one or more FECs in the urine-collection canister. It includes one or more connectors for fluid connection.

In some embodiments, the urine-draining system is pre-assembled at least partially in the FEC kit to minimize false connections and contamination based on false connections. The urine-draining tubing is fluidly connected to the urine-collecting vessel through a lid that covers the urine-collecting vessel in a partially pre-assembled urine-draining system.

In some embodiments, the FEC kit further includes a urine-privacy cover configured to form a sleeve to cover the urine-collecting container. The sleeve has a cut-out window configured to expose the graduations on the urine-collector through the window of the sleeve while the remaining portion of the urine-collector is covered by the sleeve.

In some embodiments, step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the FEC kit, and, optionally, becomes visible as one or more components of the FEC kit are removed, or a combination thereof.

In some embodiments, the packaging may include a wrap of a first sterilizable material around the components of the FEC kit or a tray of second sterilizable material on which the components of the FEC kit are located. The packaging further includes outer packaging around the wrap or tray. The outer packaging is configured to sterilize the components of the FEC kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the FEC kit.

In some embodiments, also disclosed herein is a MEC kit comprising one or more MECs, a cleaning kit, and step-by-step instructions for using the MEC kit. One or more MECs are optionally individually packaged. The cleaning kit includes one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more MECs. Step-by-step instructions for using the MEC kit include instructions for anatomical cleaning, MEC application, and MEC management after MEC application.

In some embodiments, each of the one or more MECs has the same size and color. Color is part of a color-based MEC size-indicating system where each size of the MEC has a different color, optionally according to the MEC sizer.

In some embodiments, step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the MEC kit, and, optionally, becomes visible as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof. .

In some embodiments, the packaging may include a wrap of a first sterilizable material around the components of the MEC kit or a tray of second sterilizable material on which the components of the MEC kit are located. The packaging further includes outer packaging around the wrap or tray. The outer packaging is configured to sterilize the components of the MEC kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the MEC kit.

In some embodiments, each of the one or more MECs has the same size and color. Color is part of a color-based MEC size-indicating system where each size of the MEC has a different color, optionally according to the MEC sizer. Packaging includes a wrap or tray that matches the color of one or more MECs, or an outer wrap around the wrap or tray, or a combination thereof.

Also disclosed herein is a MEC kit comprising a MEC sizer, a urine-draining system, a wash kit, and step-by-step instructions for using the MEC kit, in accordance with some embodiments. The MEC sizer has cutouts of at least 5 different sizes to determine an appropriate MEC size for the user or patient. The urine-drainage system includes a urine-collection bag, urine-drainage tubing, and a connector assembly for fluidly connecting the MEC to the urine-collection bag. The cleaning kit includes one or more individually wrapped towelettes for at least anatomical cleansing prior to MEC application. Step-by-step instructions for using the MEC kit include step-by-step instructions for anatomical cleaning, MEC application, and MEC management after MEC application.

In some embodiments, each cutout of the MEC sizer has a border with different colors around the cutout according to a color-based MEC size-indicating system.

In some embodiments, the MEC kit further includes one or more MECs. Each of the one or more MECs has a different size and color according to the color-based MEC size-indication system. One or more MECs each represent the most common MEC size or sizes.

In some embodiments, the step-by-step instructions are additionally to identify supplemental MEC kits comprising one or more supplemental MECs according to a color-based MEC size-indicating system. Supplemental kits comprising one or more supplemental MECs and at least some packaging of supplemental kits have a separate color matching the borders having different colors of the cutouts of the MEC sizer according to the color-based MEC size-indicating system.

In some embodiments, the urine-draining bag is a bedside bag or leg bag.

In some embodiments, the connector assembly includes a fixed tubing connector having a urine-sampling port, a flexible tubular bridge configured to connect to the MEC's flexible tubing connector. Each tubing connector of the flexible tubing connector and the fixed tubing connector is a bidirectional tubing connector.

In some embodiments, each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to insert into an opposite end portion of the flexible bridge. The fixed tubing connector has a non-tapered end portion configured to insert into the end portion of the urine-draining tubing. The flexible tubing connector has a non-tapered end portion configured to insert into an end portion of either MEC configured for urine drainage.

In some embodiments, the MEC kit further includes a securing device configured to secure the rigid tubing connector of the connector assembly to the patient's leg. The fixation device minimizes any longitudinal or transverse movement of the drain tubing during use.

In some embodiments, the urine-draining system is pre-assembled at least partially in the MEC kit to minimize erroneous connections and contamination based on erroneous connections. The urine-drain tubing fluidly connects the connector assembly to the urine-draining bag in a partially pre-assembled urine-draining system.

In some embodiments, step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the MEC kit, and, optionally, becomes visible as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof. .

In some embodiments, the packaging may include a wrap of a first sterilizable material around the components of the MEC kit or a tray of second sterilizable material on which the components of the MEC kit are located. The packaging further includes outer packaging around the wrap or tray. The outer packaging is configured to sterilize the components of the MEC kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the MEC kit.

In some embodiments, a MEC connector for fluidic connection of the MEC to a urine-draining system comprising a fixed tubing connector, a flexible tubing connector, and a flexible tubular bridge between the flexible tubing connector and the fixed tubing connector when the connector assembly is assembled. Assembly is also disclosed herein. The fixed tubing connector includes a urine-sampling port. The fixed tubing connector is also configured for placement in the body-adhesive fixation device. Each tubing connector of the flexible tubing connector and the fixed tubing connector is a bidirectional tubing connector. The flexible tubing connector and flexible bridge together are configured to conveniently connect the MEC to the urine-draining system.

In some embodiments, each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to insert into an opposite end portion of the flexible bridge.

In some embodiments, the fixed tubing connector has a non-tapered end portion configured to insert into the end portion of the urine-draining tubing of the urine-draining system.

In some embodiments, the flexible tubing connector has a non-tapered end portion configured to insert into the open end portion of the MEC.

In some embodiments, a flexible tubing connector includes a plurality of columnar ridges on the non-tapered end portion configured to provide resistance to the MEC from sliding out of the non-tapered end portion while the MEC is in use. ridges).

These or other features of the concepts provided herein will become apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose specific embodiments of these concepts in more detail.

1A provides a first form of MEC in accordance with some embodiments.
1B provides a second style of MEC in accordance with some embodiments.
1C provides a third form of MEC in accordance with some embodiments.
1D provides a MEC disposed over a plastic insert in accordance with some embodiments.
2 provides an FEC according to some embodiments.
3A provides a connector assembly for a MEC disposed in a fixed device in accordance with some embodiments.
3B provides a cross section of a connector assembly for a MEC disposed in a fixed device in accordance with some embodiments.
3C provides a cross section of a connector assembly for a MEC disposed in a fixed device in accordance with some embodiments.
3D provides a close-up view of a portion of the connector assembly of FIG. 3B in accordance with some embodiments.
3E provides a cross section of a connector assembly for a MEC disposed in a fixed device in accordance with some embodiments.
4A provides an FEC assembly fluidly connected to a house-vacuum system in accordance with some embodiments.
4B provides an FEC assembly fluidly connected to a standalone vacuum pump in accordance with some embodiments.
5A provides a MEC kit in accordance with some embodiments.
5B provides a MEC kit in accordance with some embodiments.
6A provides an FEC kit in accordance with some embodiments.
6B provides an FEC kit in accordance with some embodiments.

Before some specific embodiments are disclosed in more detail, it is to be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. Certain embodiments disclosed herein can be easily separated from the specific embodiments, and features that can be selectively combined with or substituted for any one of a number of other embodiments disclosed herein. It will also be understood that it can have.

With respect to terms used herein, it should also be understood that the terms are for describing some specific embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (eg, first, second, third, etc.) are generally used to distinguish or identify different steps or features in a group of steps or features, and do not provide an order or numerical limitation. For example, the “first”, “second”, and “third” features or steps need not necessarily appear in that order, and certain embodiments including these features or steps may include three features. Or it does not necessarily have to be limited to steps. “Left”, “Right”, “Forward”, “Rear”, “Top”, “Bottom”, “Forward”, “Back”, “Clockwise”, “Counterclockwise”, “Up”, “Down” Labels such as ”, or other similar terms are used for convenience and do not mean, for example, any particular fixed position, orientation or orientation. Instead, these labels are used to indicate, for example, relative position, orientation or orientation. The singular forms of “one (a)”, “an”, and “the” include plural references unless the context dictates otherwise.

Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by those of ordinary skill in the art.

Hospitals across the country are naturally focusing their efforts on reducing the risk of CAUTIs, at least in response to the large penalties imposed by the ACA.

Steps taken to reduce the risk of indwelling catheter-related infections include reducing the utilization of indwelling catheters through the use of non-indwelling catheter alternatives as well as implementation of various prophylactic methodologies recommended by the CDC. With the use of non-attracting catheter alternatives, such as external catheters that are expected to increase, problems related to the application and management of already applied catheters are also expected to increase.

External catheters, external catheter-related components, external-catheter kits with step-by-step instructions, and methods thereof that provide a standardized system for the application and management of these catheters are disclosed herein.

Male external catheter (MEC)

1A-1D illustrate multiple MECs in accordance with some embodiments. These MECs may have sheaths of latex, non-latex such as silicone, or non-latex such as polyurethane and non-silicone. Non-latex sheaths, such as silicone sheaths, provide better breathability than latex sheaths. These MECs may include adhesives for self-adhesive sheaths. MECs without self-adhesive sheaths use adjustable straps over the MECs instead of adhesive.

1A provides a first form of unrolled MEC 110A in accordance with some embodiments.

As shown, MEC 110A has a more conventional sheet length (for example, a sheath length of about 3'') and an adhesive band 112 along the length of the silicone sheath. The adhesive may be a hydrocolloid adhesive that is incorporated into the lining of the sheath around the middle section of MEC 110A. The width of the adhesive band 112 may be about 1.75'' along the middle section of the MEC 110A. The combination of silicone sheath and hydrocolloid adhesive provides a flexible and breathable MEC 110A that removes moisture when worn.

1B provides a second form of unfolded MEC 110B in accordance with some embodiments.

As shown, MEC 110B has a shorter sheath length (e.g., about 1.5'' sheath length) and an adhesive band 112 disposed forward along the length of the silicone sheath. The adhesive may be a hydrocolloid adhesive that is incorporated into the lining of the sheath around the middle section of MEC 110B. The width of the adhesive band 112 may be about 1.75'' along the middle region of the MEC 110B, which provides a maximum of adhesive over the length of the sheath. The combination of silicone sheath and hydrocolloid adhesive provides a flexible and breathable MEC 110B that removes moisture when worn.

1C provides a first form of unrolled MEC 110C in accordance with some embodiments.

As shown, the MEC 110C has a more conventional sheath length (e.g., a sheath length of about 3'') and an adhesive band 112 disposed forward along the length of the silicone sheath. The adhesive may be a hydrocolloid adhesive that is incorporated into the lining of the sheath around the middle section of MEC 110C. The width of the adhesive band 112 may be about 3.00'' along the middle region of MEC 110B, which provides a maximum of adhesive over the length of the sheath compared to MEC 110A. The combination of silicone sheath and hydrocolloid adhesive provides a flexible and breathable MEC 110C that removes moisture when worn.

FIG. 1D provides an unfolded MEC like any one of MECs 110A, 110B, and 110C disposed on the plastic insert 111 according to some embodiments.

As shown, a rolled MEC, such as the MEC of any of the MECs 110A, 110B, and 110C, is placed over the plastic insert 111 to maintain the structural integrity of the MEC prior to use. Any of the MECs described herein may be packaged with a plastic insert that is easily removed by pulling the MEC away from the plastic insert as shown.

Each MEC of MECs 110A, 110B, and 110C is 25 mm (“small”), 29 mm (“medium”), 32 mm (“center”), 36 mm ( "Large"), and 41 mm ("very large").

Each of the MECs 110A, 110B, and 110C of the same size may be manufactured to have a conventional color by adding a dye to the raw material to produce MECs of the same size. As described herein, each MEC of MECs 110A, 110B, and 110C includes a flexible connector 384, which flexible connector 384 may have the same color as the MEC into which it is inserted. . The color is a color-based MEC size-indicator system in which each size of MEC has different colors depending on the MEC sizer (see MEC sizer 560 of FIG. 5B). Is part of. Alternatively, MEC attachments with color according to a color-based MEC size-indicating system can be used to indicate the associated MEC size. For example, a band with color can be placed around the MEC or MEC-related components to indicate the associated MEC size.

The hydrocolloidal adhesive of each MEC of MECs 110A, 110B, and 110C maintains adhesion while maintaining skin integrity without skin maceration.

External Cancer Catheter (FEC)

2 provides an FEC 210 in accordance with some embodiments.

As shown, the FEC 210 includes a gauze 212 covering an aperture in the elongated body 214. The aperture is fluidly connected to the urine-draining tubing 216, which is configured to connect to the urine-draining tubing of the urine-draining system (urine-draining tubing 642 in Figure 6B and the urine-draining tubing 642 in Figures 4A and 4B). -See drainage system (440)). The gauze 212 is configured to collect urine over the length and width of the aperture in the elongated body 214, and when the FEC 210 is connected to a light weight vacuum source (e.g., 40 mm Hg), Urine is absorbed through the aperture and urine-drain tubing 216.

While the FEC 210 is primarily configured for catheterization outside the cancer, it is small, buried (i.e. hidden underneath anatomical structures such as the abdomen, thighs or scrotum) or inverted male body structures. For this, a vacuum-assisted external catheter such as FEC 210 is required. Thus, FEC 210, or a modified version thereof, may be used for male external catheterization if necessary.

MEC-related components

3A provides a connector assembly 380 for a MEC, such as MECs 110A, 110B, or 110C disposed in a fixing device 370 in accordance with some embodiments. 3B, 3C, and 3E provide various cross-sections of a connector assembly 380 disposed in a fixing device 370 according to some embodiments. 3D provides a close-up view of a portion of the connector assembly 380 of FIG. 3B in accordance with some embodiments.

As shown, the connector assembly 380 is a flexible tubular bridge between the fixed tubing connector 384 and the fixed tubing connector 382 of the MEC when the fixed tubing connector 382 and connector assembly 380 are assembled. 386). The fixed tubing connector 382 includes a urine-sampling port 388.

Each of the tubing connectors of the flexible tubing connector 384 and the fixed tubing connector 382 is a bidirectional tubing connector. Each tubing connector of flexible tubing connector 384 and fixed tubing connector 382 also has a tapered end portion that is configured to insert into an opposite end portion of flexible bridge 386. The fixed tubing connector 382 has a non-tapered end portion that is configured to insert into the end portion of the urine-draining tubing of the urine-draining system. Flexible tubing connector 384 has a non-tapered end portion configured to insert into the open end portion of any MEC configured for urine drainage.

The flexible tubing connector 384 and the flexible bridge 386 together are configured to conveniently fluidically connect the MEC to the urine-draining system, which in some embodiments forms part of the connector assembly 380 of the urine-draining system (Fig. 5b, urine-drainage system 540). The flexible tubing connector 384 has a plurality of columnar ridges on the non-tapered end portion that is configured to provide resistance to the MEC from slipping out of the non-tapered end portion while the MEC is in use. I can.

The fixed tubing connector 382 may be configured for placement in a body adhesive fixation device, such as the fixation device 370. The fixed device 370 includes, but is not limited to, a StatLock® device (C. R. Bard, Inc., Murray Hill, New Jersey, USA), and the like.

FEC-related components

4A provides an FEC 210 fluidly connected to a house-vacuum system 490A in accordance with some embodiments.

As shown, FEC 210 fluidly connects via urine-draining system 440 to a lightweight vacuum source (e.g., 40 mm Hg) such as house-vacuum system 490A or standalone vacuum pump 490B. do. The urine-draining system includes a urine-collecting container 644, a lid 646 configured to cover the urine-collecting container 644, and a urine-draining tubing 642, which is shown in FIG. It is described with reference. When the FEC 210 is connected to a lightweight vacuum source, urine may be absorbed through the urine-draining tubing 216 and aperture of the FEC 210.

External-catheter kits

External-catheter kits can include starter kits and supplemental kits, which standardize external catheter insertion and minimize procedural changes for better results. Starter kits include most (if not all) disposable and multi-use components necessary for anatomical cleaning, external-catheter application, and some external-catheter care after external-catheter application. Supplemental kits generally include disposable components to supplement the commonly used disposable components of starter kits. That is, due to the different forms and sizes of MECs, a starter kit for external male catheterization may optionally include one or more MECs. Where such a starter kit does not contain one or more MECs, a supplemental kit comprising one or more MECs supplements and completes the starter kit. These starter and supplement kits are described in more detail below.

Starting with a supplemental kit for external catheter insertion, these external-catheter kits include, in some embodiments, one or more catheters, a cleaning kit, and step-by-step instructions for using the external-catheter kit. Cleaning kits include individually wrapped towels (eg, castile soap wipes) for at least anatomical cleaning prior to application of any external catheter of one or more external catheters. The cleaning kit may optionally further comprise at least one pair or more test gloves for anatomical cleaning. Step-by-step instructions for using an external-catheter kit include step-by-step instructions for anatomical cleaning, external-catheter application, and external-catheter management after external-catheter application.

Referring to starter kits for external catheterization, these external-catheter kits further comprise a urine-draining system (ie, other than a component of the supplemental kits). The urine-draining system includes a urine-collection container, a urine-drainage tubing, and one or more connectors for fluidly connecting the external catheter of one or more external catheters to the urine-collection device. The urine-draining system is pre-assembled at least partially in an external-catheter kit to minimize contamination based on erroneous connections and erroneous connections, which can arise from mismanaged components of the urine-drainage system. The urine-draining tubing is fluidly connected to the urine-collection container in a partially pre-assembled urine-draining system.

Regardless of the starter kit or supplemental kit for external catheter insertion, step-by-step instructions for using the external-catheter kit are provided in a booklet in picture book format. The booklet allows step-by-step instructions to be conveniently placed slightly away from the external-catheter kit. Alternatively, step-by-step instructions are integrated with the packaging for an external-catheter kit. Optionally, the integrated instructions become visible as one or more components of the external-catheter kit are removed from the external-catheter kit. Step-by-step instructions, which are a combination of package and booklet, may be provided in an external-catheter kit. Labels for the components of the external-catheter kit are used with step-by-step instructions. These labels may be on the packaging or on the components for the components.

The packaging of either a starter kit or supplemental kit for external catheterization may include a wrap of a first sterilizable material (eg, a central supply room [“CSR”] wrap) around the components of the external-catheter kit. have. Alternatively, the package may include a tray of second sterilizable material on which the components of the outer-catheter kit are located. Labels for the components of the external-catheter kit used with step-by-step instructions may be on a wrap or tray. The packaging may further include a wrap or outer packaging around the tray. The outer packaging may be configured to sterilize the components of the outer-catheter kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the outer-catheter kit. That is, the external-catheter kit does not need to be sterilized.

Male external-catheter kits

Again, external-catheter kits, including MEC kits, may include starter kits and supplementary kits. Starter kits for male external catheterization generally include most (if not all) disposable and multi-use components required for anatomical cleaning, MEC application, and some external-catheter care after MEC application. Supplemental kits for male external catheterization generally include disposable components to supplement the commonly used disposable components of starter kits. That is, due to the different modalities and sizes of MECs, a starter kit for male external catheterization may optionally include one or more MECs. If such a starter kit does not contain one or more MECs, the supplemental kit comprising one or more MECs supplements and thus completes the starter kit. These starter and supplement kits are described in more detail below.

Starting with a supplemental kit for male external catheterization, Figure 5A provides such a MEC kit 500A in accordance with some embodiments.

As shown, MEC kit 500A includes one or more MECs 510, cleaning kit 520, and step-by-step instructions 530 for using MEC kit 500A. One or more MECs 510 are optionally individually packaged. The cleaning kits include one or more individually wrapped towels (eg, castile soap wipes) for at least anatomical cleaning prior to application of any of the one or more MECs 510. The cleaning kit 520 may optionally further include at least one pair of test gloves 524 for anatomical cleaning. Step-by-step instructions 530 for using the MEC kit 500A include step-by-step instructions for anatomical cleaning, MEC application, and MEC management after MEC application.

Each MEC of one or more MECs 510 of MEC kit 500A has the same size and color. Each MEC of MECs 510 may include a flexible connector 384, which may have the same color as the MEC into which it is inserted. Color is part of a color-based MEC size-indicator system in which each size MEC optionally has a different color according to the MEC sizer. Alternatively, MEC attachments with color according to a color-based MEC size-indicating system can be used to indicate the associated MEC size. For example, a band with color may be placed around the MEC or one or more MEC-related components to indicate the associated MEC size. The packaging of the MEC kit 500A, described in more detail below, includes a wrap or tray, an outer package, or a combination thereof (eg, an outer wrap around a wrap or tray). This packaging may match the color of one or more MECs 510 (or attachments) according to a color-based MEC size-indicating system.

Referring to a starter kit for male external catheter insertion, FIG. 5B provides such a MEC kit 500B according to some embodiments.

As shown, MEC kit 500B includes one or more MECs 510 (optionally, individually packaged). However, these MECs are optional in starter kits for male external catheterization due to the different modalities and sizes of MECs. If such a starter kit includes one or more MECs 510, each MEC of one or more MECs 510 has a different size. In addition, each MEC of the one or more MECs 510 may have a different color according to the color-based MEC size-display system (each MEC of the one or more MECs 510 of the MEC kit 500A is the same. Note that it has a size and color). Alternatively, MEC attachments with color according to a color-based MEC size-indicating system can be used to indicate the associated MEC size. For example, a band with color may be placed around the MEC or one or more MEC-related components to indicate the associated MEC size. One or more MECs 510 each represent at least the most common MEC size or sizes. That is, one or more MECs may be MECs having five different sizes corresponding to the MEC sizer 560.

The MEC kit 500B further includes a MEC sizer 560 (ie, in addition to the components of the MEC kit 500A). The MEC sizer 560 has cutouts of at least five different sizes to determine an appropriate MEC size for a user or patient. Each cutout of the cutouts of the MEC sizer 560 may have a border 564 having different colors around the cutout 562 according to the color-based MEC size-indicating system. The MEC sizer 560 can be used to select one of MECs 510 having one or more different sizes, if present, or the MEC sizer 560 is the same number as the MEC kit 500A. It can be used to select a supplemental kit for catheterization. The MEC kit 500B further includes a urine-draining system 540. Urine-draining system 540 includes a urine-collecting bag 544, urine-draining tubing 542, and a connector assembly 380 for fluidly connecting one MEC to the urine-collecting bag 544. Urine-collecting bag 544 is a bedside bag or leg bag.

The connector assembly 380 includes a fixed tubing connector 382 having a urine-sampling port 388, and a flexible tubular bridge 386 configured to connect to the MEC's flexible tubing connector 384 (Figure 3A). 3E), the connector assembly 380 is a flexible tubing connector 384 of one of the one or more MECs 510 to fluidly connect to the urine-collecting bag 544 via urine-draining tubing 542. It is configured through a flexible bridge 386 to conveniently connect to. Each tubing connector of the flexible tubing connector 384 and the fixed tubing connector 382 is a bidirectional connector. Each tubing connector of flexible tubing connector 384 and fixed tubing connector 382 may have tapered end portions that are configured to insert into opposite end portions of flexible bridge 386. Fixed tubing connector 382 has a non-tapered end portion configured to insert into the end portion of urine-draining tubing 542. The flexible tubing connector 384 has a non-tapered end portion configured to insert into an end portion of any MEC configured for urine drainage.

Urine-draining system 540 is pre-assembled at least partially in MEC kit 500B to minimize contamination based on false connections and false connections. Urine-draining tubing 542 fluidly connects connector assembly 380 to urine-collecting bag 544 in a partially pre-assembled urine-draining system 540.

The MEC kit 500B further includes a fixation device 370 configured to fix the fixed tubing connector 382 of the connector assembly 380 to the patient's leg. The securing device 370 minimizes any longitudinal or transverse movement of the drain tubing during use. Such fixed devices 370 include, but are not limited to, StatLock® devices (C. R. Bard, Inc., Murray Hill, New Jersey, USA), and the like.

Regardless of the starter kit or supplemental kit for male catheterization, step-by-step instructions for using the MEC kit are provided in a booklet in picture book format. The booklet allows step-by-step instructions to be conveniently placed slightly away from the MEC kit. Alternatively, step-by-step instructions are integrated with the packaging for the MEC kit. Optionally, the integrated instructions become visible as one or more components of the MEC kit are removed from the MEC kit. Step-by-step instructions may be provided in the MEC kit, which are a combination of packaging and booklets. Labels for the components of the MEC kit are used with step-by-step instructions. These labels may be on the packaging or components for the components.

Step-by-step instructions (especially those in starter kits for male external catheter insertion) are additionally to identify supplemental kits for male external catheter insertion comprising one or more MECs according to a color-based MEC size-indicating system. . Supplemental kits comprising one or more supplemental MECs and at least some packaging of supplemental kits are individually matched with different colored borders of the cutouts of MEC sizer 560 according to a color-based MEC size-indicating system. Have color.

The packaging of either a starter kit or supplemental kit for male external catheterization may include a wrap of a first sterilizable material (eg, a CSR wrap) around the components of the MEC kit. Alternatively, the packaging may include a tray of second sterilizable material on which the components of the MEC kit are placed. Labels for components of the MEC kit used with step-by-step instructions can be on a wrap or tray. The packaging may further include a wrap or outer packaging around the tray. The outer packaging may be configured to sterilize the components of the MEC kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the MEC kit. That is, the MEC kit does not need to be sterilized.

Although not shown in FIGS. 5A or 5B, the starter kit or supplement kit for male external catheterization is configured to indicate that a predetermined amount of time has elapsed since connecting the MEC to urine-collecting bag 544. It may further include a time indicator. This is useful for reminding the user or patient to replace the MEC after a predetermined amount of time has elapsed. The predetermined amount of time may be at least 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, or 24 hours. The predetermined amount of time may be 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, or 4 hours or less. As such, the predetermined amount of time may be at least 4 hours and 24 hours or less, including at least 8 hours and 20 hours or less, for example, 12 hours or at least 8 hours and 16 hours or less.

The visual duration indicator is configured for activation that initiates a predetermined amount of time during one or more steps of the process for connecting the MEC to the urine-collection bag 544. Activation is peeling off the adhesive backing of the components of the MEC kit 500A or 500B, or the component of the MEC kit 500A or 500B (e.g., color according to a color-based MEC size-indication system). Branches, including popping fluid-filled blisters on MEC attachments), initiate chemical shifts, chemical reactions, or a combination thereof to create an identifiable visual endpoint indicating that a predetermined amount of time has elapsed. , Is not limited thereto. Prior to connecting the MEC to the urine-collection bag 544 or after the visual duration indicator is activated at the time point, the visual duration indicator changes color to the user or patient to replace the MEC after a predetermined amount of time has elapsed. Remind.

Cancer external-catheter kits

Again, external-catheter kits, including FEC kits, can include starter kits and supplementary kits. Starter kits contain most (if not all) disposable and multi-use components required for anatomical cleaning, FEC application, and some external-catheter care after FEC application. Supplemental kits for catheterization outside the arm generally include disposable components to supplement the commonly used disposable components of starter kits.

Starting with a supplemental kit for catheterization outside the arm, FIG. 6A provides such an FEC kit 600A in accordance with some embodiments.

As shown, the FEC kit 600A includes one or more MECs 610, a cleaning kit 620, and step-by-step instructions 630 for using the FEC kit 600A. One or more FECs 610 are optionally individually packaged. The cleaning kits include one or more individually wrapped towels (eg, Castile soap towels) for at least anatomical cleaning prior to application of any of the one or more FECs 610. The cleaning kit 620 may optionally further include at least one pair of test gloves 624 for anatomical cleaning. Step-by-step instructions 630 for using the FEC kit 600A include step-by-step instructions for anatomical cleaning, FEC application, and FEC management after FEC application.

Referring to a starter kit for catheterization outside the arm, FIG. 6B provides such an FEC kit 600B according to some embodiments.

As shown, the FEC kit 600B further includes a urine-draining system 440 (see FIGS. 4A and 4B) (ie, in addition to the components of the FEC kit 600A). The urine-draining system 440 includes a urine-collecting vessel 644, a lid 646 configured to cover the urine-collecting vessel 644, and a urine-draining tubing 642, and a urine-collecting vessel 644. And one or more connectors, such as a connector 643, which fluidly connects one of the one or more FECs 610 to.

Urine-draining system 540 is pre-assembled at least partially in FEC kit 600B to minimize contamination based on false connections and false connections. The urine-draining tubing 642 is fluidly connected to the urine-collecting container 644 through a lid 646 that covers the urine-collecting container 644 in a partially pre-assembled urine-draining system 440.

The FEC kit 600B further includes a urine-privacy cover 648 configured to form a sleeve for covering the urine-collecting container 644. The sleeve is a cut-out window configured to expose the graduations on the urine-collector 644 through the window 649 of the sleeve while the remaining portion of the urine-collector 644 is covered by the sleeve. out window)(649).

Although not shown, the FEC kit 600B further includes a fixation device configured to secure the urine-draining tubing 642 of the urine-draining system 440 to the patient's leg or other part of the patient's body. The fixation device minimizes any longitudinal or transverse movement of urine-draining tubing 642 during use. Such fixed devices include, but are not limited to, StatLock® devices (C. R. Bard, Inc., Murray Hill, New Jersey, USA) and the like.

Regardless of the starter kit or supplemental kit for female catheterization, step-by-step instructions for using the FEC kit are provided in a booklet in picture book format. The booklet allows step-by-step instructions to be conveniently placed slightly away from the FEC kit. Alternatively, step-by-step instructions are integrated with the packaging for the FEC kit. Optionally, integrated instructions become visible as one or more components of the FEC kit are removed from the FEC kit. Step-by-step instructions may be provided in the FEC kit, which are a combination of packaging and booklets. Labels for the components of the FEC kit are used with step-by-step instructions. These labels may be on the packaging or components for the components.

The packaging of either a starter kit or supplemental kit for catheterization outside the arm may include a wrap of a first sterilizable material (eg, a CSR wrap) around the components of the FEC kit. Alternatively, the packaging may include a tray of second sterilizable material on which the components of the FEC kit are placed. Labels for the components of the FEC kit used with step-by-step instructions may be on a wrap or tray. The packaging may further include a wrap or outer packaging around the tray. The outer packaging may be configured to sterilize the components of the FEC kit in a wrap or tray within the outer packaging with sterile gas prior to sealing the FEC kit. That is, the FEC kit does not need to be sterilized.

Although not shown in Figures 6A or 6B, the starter kit or supplement kit for catheterization outside the arm is configured to indicate that a predetermined amount of time has elapsed since connecting the FEC to the urine-collecting container 644. It may further include a time indicator. This is useful for reminding the user or patient to replace the FEC after a predetermined amount of time has elapsed. The predetermined amount of time may be at least 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, or 24 hours. The predetermined amount of time may be 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, or 4 hours or less. As such, the predetermined amount of time may be at least 4 hours and 24 hours or less, including at least 8 hours and 20 hours or less, for example, 12 hours or at least 8 hours and 16 hours or less.

The visual duration indicator is configured for activation that initiates a predetermined amount of time during one or more steps of the process for connecting the FEC to the urine-collector 644. Activation involves peeling off the adhesive backing of the components of the FEC kit (600A or 600B), or popping a fluid-filled blister on the components of the FEC kit (600A or 600B). Initiate a migration, chemical reaction, or combination thereof to create an identifiable visual endpoint indicating that a predetermined amount of time has elapsed, but is not limited thereto. Prior to connecting the FEC to the urine-collecting container 644 or after the visual duration indicator is activated at the time point, the visual duration indicator changes color after a predetermined amount of time has elapsed to allow the user or patient to replace the FEC. Remind.

Methods

Methods of external catheters, external catheter-related components, or external-catheter kits include methods of making or using external catheters, external catheter-related components, or external-catheter kits. For example, methods of making external-catheter kits include kitting the components of the external-catheter kits, optionally sterilizing the components of the external-catheter kits, and sealing the external-catheter kits. Include. For example, the method of using external-catheter kits is standardized for application and management of external catheters while minimizing procedural changes by following the steps of opening external-catheter kits and step-by-step instructions provided for external-catheter kits And following the system.

While some specific embodiments have been disclosed herein and specific embodiments have been disclosed in some detail, they are not intended to limit the scope of the concepts provided herein. Additional adaptations and/or variations may be apparent to those of ordinary skill in the art, and in a broader aspect, adaptations and/or variations thereof are included. Accordingly, it may be made from specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims (42)

In the external-catheter kit,
One or more external catheters;
A cleaning kit comprising one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more external catheters; And
Step-by-step instructions for the anatomical cleaning, external-catheter application, and external-catheter management after the external-catheter application;
Containing,
External-catheter kit.
The method of claim 1,
A urine-draining system comprising a urine-collecting container, a urine-draining tubing, and one or more connectors for fluidly connecting an external catheter of one of the one or more external catheters to the urine-collecting device;
Containing more
External-catheter kit.
The method of claim 2,
The urine-draining system is at least partially pre-assembled in the external-catheter kit to minimize contamination based on erroneous connections and erroneous connections, and the urine-draining tubing is in the partially pre-assembled urine-draining system. Fluidly connected to the urine-collecting container,
External-catheter kit.
The method of claim 1,
The one or more external catheters are female external catheters (“FEC”), and the one or more FECs are optionally individually packaged,
External-catheter kit.
The method of claim 4,
A urine-collection canister, a lid configured to cover the urine-collection canister, a urine-draining tubing, and fluid connection of one of the one or more FECs to the urine-collection canister An FEC urine-draining system comprising one or more connectors for;
Further comprising,
External-catheter kit.
The method of claim 5,
The FEC urine-draining system is at least partially pre-assembled in the outer-catheter kit to minimize contamination based on erroneous connections and erroneous connections, and the urine-draining tubing is the partially pre-assembled FEC urine-draining system. Fluidly connected to the urine-collector through the lid covering the urine-collector in the system,
External-catheter kit.
The method according to claim 5 or 6,
Further comprising a urine-privacy cover configured to form a sleeve (sleeve) for covering the urine-collecting container, wherein the sleeve is covered by the sleeve in the remaining portion of the urine-collecting container Having a cut-out window configured to expose the graduations on the urine-collector through the window of the sleeve while being
External-catheter kit.
The method of claim 1,
The one or more external catheters are male external catheter (“MEC”), and the one or more MECs are optionally individually packaged,
External-catheter kit.
The method of claim 8,
Each of the one or more MECs has a different size, and the one or more MECs each represent the most common MEC size or sizes,
External-catheter kit.
The method according to claim 8 or 9,
A MEC sizer having cutouts of at least five different sizes to determine an appropriate MEC size for a user or patient;
Further comprising,
External-catheter kit.
The method of claim 10,
Each cutout of the cutouts has a border with different colors around the cutout according to a color-based MEC size-indicating system, and each MEC of the one or more MECs is in the MEC size-indicating system. Have different colors depending on the
External-catheter kit.
The method according to any one of claims 8 to 10,
A MEC urine-draining system comprising a urine-collecting bag, a urine-draining tubing, and a connector assembly for fluidly connecting the MEC of one of the one or more MECs to the urine-collecting bag;
Further comprising,
External-catheter kit.
The method of claim 12,
The urine-draining bag is a bedside bag or a leg bag,
External-catheter kit.
The method of claim 12 or 13,
The connector assembly includes a fixed tubing connector having a urine-sampling port, and a flexible tubular bridge configured to connect to a flexible tubing connector of MEC, and each tubing connector of the flexible tubing connector and the fixed tubing connector is bidirectional tubing Connector,
External-catheter kit.
The method of claim 14,
Each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to be inserted into an opposite end portion of the flexible bridge, the fixed tubing connector comprising an end portion of the urine-draining tubing Having a non-tapered end portion configured to insert into the portion, and the flexible tubing connector has a non-tapered end portion configured to insert into an end portion of any one of the one or more MECs configured for urine drainage,
External-catheter kit.
The method of claim 14 or 15,
A securing device configured to secure the stationary tubing connector of the connector assembly to a patient's leg to minimize any longitudinal or transverse movement of the drain tubing during use;
Further comprising,
External-catheter kit.
The method according to any one of claims 12 to 16,
The MEC urine-drainage system is at least partially pre-assembled in the outer-catheter kit to minimize contamination based on false connections and false connections, and the urine-draining tubing is partially pre-assembled MEC urine-draining Fluidly connecting the connector assembly to the urine-draining bag in a system,
External-catheter kit.
The method according to any one of claims 1 to 17,
The step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the outer-catheter kit, and optionally, becomes visible as one or more components of the outer-catheter kit are removed from the outer-catheter kit, or A combination of these,
External catheter kit.
One or more FECs;
A cleaning kit comprising one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more FECs; And
Step-by-step instructions for the anatomical cleaning, FEC application, and FEC management after the FEC application;
Containing,
External Arm Catheter (“FEC”) Kit.
The method of claim 19,
A urine-collection canister, a lid configured to cover the urine-collection canister, a urine-draining tubing, and fluid connection of one of the one or more FECs to the urine-collection canister A urine-draining system comprising one or more connectors for making it possible to;
Further comprising,
External Arm Catheter (“FEC”) Kit.
The method of claim 20,
The urine-draining system is at least partially pre-assembled in the FEC kit to minimize contamination based on erroneous connections and erroneous connections, and the urine-draining tubing is provided with the urine in the partially pre-assembled urine-draining system. -Fluidly connected to the urine-collection container through the lid covering the collection container,
External Arm Catheter (“FEC”) Kit.
The method of claim 20 or 21,
Further comprising a urine-privacy cover configured to form a sleeve (sleeve) for covering the urine-collecting container, wherein the sleeve is covered by the sleeve in the remaining portion of the urine-collecting container Having a cut-out window configured to expose the graduations on the urine-collector through the window of the sleeve while being
External Arm Catheter (“FEC”) Kit.
The method according to any one of claims 19 to 22,
The step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the FEC kit, and, optionally, becomes visible as one or more components of the FEC kit are removed, or a combination thereof,
External Arm Catheter (“FEC”) Kit.
One or more MECs;
A cleaning kit comprising one or more individually wrapped towelettes for at least anatomical cleansing prior to application of any one of the one or more MECs; And
Step-by-step instructions for the anatomical cleaning, MEC application, and MEC management after the MEC application;
Containing,
Male external catheter (“MEC”) kit.
The method of claim 24,
Each MEC of the one or more MECs has the same size and color, the color being part of a color-based MEC size-indicating system having a different color, with each size of the MEC, optionally depending on the MEC sizer,
Male external catheter (“MEC”) kit.
The method of claim 24,
The step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the MEC kit, and is optionally made visible as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof,
Male external catheter (“MEC”) kit.
The method of claim 26,
Each MEC of the one or more MECs has the same size and color, the color is part of a color-based MEC size-indicating system having a different color, each size of the MEC, optionally according to the MEC sizer, And the packaging comprises a wrap or tray matching the color of the one or more MECs, or an outer packaging around the wrap or the tray, or a combination thereof,
Male external catheter (“MEC”) kit.
A MEC sizer having cutouts of at least five different sizes to determine an appropriate MEC size for a user or patient;
A urine-draining system comprising a urine-collecting bag, a urine-draining tubing, and a connector assembly for fluidly connecting the MEC to the urine-collecting bag;
A cleaning kit comprising one or more individually wrapped towelettes for at least anatomical cleansing prior to MEC application; And
Step-by-step instructions for the anatomical cleaning, MEC application, and MEC management after the MEC application;
Containing,
Male external catheter (“MEC”) kit.
The method of claim 28,
Each cutout of the MEC sizer has a border with different colors around the cutout according to a color-based MEC size-indicating system,
Male external catheter (“MEC”) kit.
The method of claim 29,
One or more MECs;
Including more,
Each MEC of the one or more MECs has a different size and color according to the color-based MEC size-indication system, and the one or more MECs each represent the most common MEC size or sizes,
Male external catheter (“MEC”) kit.
The method of claim 29 or 30,
The step-by-step instructions are further for identifying supplemental MEC kits comprising one or more supplemental MECs according to the color-based MEC size-indicating system, and at least of the supplemental kits and the supplemental kits comprising the one or more supplemental MECs. Some packaging has a separate color matching borders having different colors of the cutouts of the MEC sizer according to the color-based MEC size-indicating system,
Male external catheter (“MEC”) kit.
The method according to any one of claims 28 to 31,
The urine-draining bag is a bedside bag or a leg bag,
Male external catheter (“MEC”) kit.
The method according to any one of claims 28 to 32,
The connector assembly includes a fixed tubing connector having a urine-sampling port, a flexible tubular bridge configured to connect to a flexible tubing connector of MEC, and each tubing connector of the flexible tubing connector and the fixed tubing connector is a bidirectional tubing connector. sign,
Male external catheter (“MEC”) kit.
The method of claim 33,
Each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to be inserted into an opposite end portion of the flexible bridge, the fixed tubing connector comprising an end portion of the urine-draining tubing Having a non-tapered end portion configured to insert into the portion, and the flexible tubing connector has a non-tapered end portion configured to insert into the end portion of either MEC configured for urine drainage,
Male external catheter (“MEC”) kit.
The method of claim 33 or 34,
A securing device configured to secure a stationary tubing connector of the connector assembly to a patient's leg to minimize any end or transverse movement of the drain tubing during use;
Further comprising,
Male external catheter (“MEC”) kit.
The method according to any one of claims 28 to 35,
The urine-draining system is at least partially pre-assembled in the MEC kit to minimize contamination based on erroneous connections and erroneous connections, and the urine-draining tubing is partially pre-assembled in the urine-draining system. -Fluidly connecting the connector assembly to the drain bag,
Male external catheter (“MEC”) kit.
The method according to any one of claims 28 to 36,
The step-by-step instructions are provided in a booklet in the form of a picture book, which is integrated with the packaging for the MEC kit, and is optionally made visible as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof,
Male external catheter (“MEC”) kit.
A male external catheter (“MEC”) connector assembly for fluid connection of the MEC to a urine-draining system, comprising:
A fixed tubing connector comprising a urine-sampling port, the fixed tubing connector configured to be placed in a body adhesive fixation device;
A flexible tubing connector, wherein each tubing connector of the flexible tubing connector and the fixed tubing connector is a bidirectional tubing connector; And
A flexible tubular bridge between the flexible tubing connector and the fixed tubing connector when the connector assembly is assembled, the flexible tubing connector and the flexible bridge together configured to conveniently connect the MEC to a urine-draining system;
Containing,
Male external catheter (“MEC”) connector assembly.
The method of claim 38,
Each tubing connector of the flexible tubing connector and the fixed tubing connector has a tapered end portion configured to insert into an opposite end portion of the flexible bridge,
Male external catheter (“MEC”) connector assembly.
The method of claim 38 or 39,
The fixed tubing connector has a non-tapered end portion configured to insert into an end portion of a urine-draining tubing of the urine-draining system,
Male external catheter (“MEC”) connector assembly.
The method according to any one of claims 38 to 40,
The flexible tubing connector has a non-tapered end portion configured to insert into the open end portion of the MEC,
Male external catheter (“MEC”) connector assembly.
The method of claim 41,
The flexible tubing connector has a plurality of columnar ridges on the non-tapered end portion configured to provide resistance to the MEC from sliding out of the non-tapered end portion while the MEC is in use. ,
Male external catheter (“MEC”) connector assembly.

Images